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Biological Markers and Advanced Imaging for Prostate Cancer Progression in Active Surveillance

NCT06866041 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2025-05-16

No results posted yet for this study

Summary

This study aims to identify patients with low-risk prostate cancer (ISUP Grade Group 1) eligible for active surveillance who are at higher risk of upgrading to ISUP Grade Group 2 or higher at confirmatory biopsy one year after diagnosis. Patients with low-risk ISUP GG1 tumors will be selected and undergo:

* PSMA PET with calculation of SUVmax and PRIMARY-Likert score
* Whole Exome Sequencing (WES) analysis on diagnostic prostate biopsies
* Immunohistochemistry on diagnostic prostate biopsies
* Confirmatory biopsy one year after diagnosis, as recommended by international guidelines This prospective, monocentric, single-arm interventional study will assess the predictive accuracy of a multivariable model integrating next-generation imaging and molecular biomarkers to improve risk stratification in active surveillance patients.

Conditions

  • Low-Risk Prostate Cancer

Interventions

PROCEDURE

mpMRI-targeted confirmatory biopsy

mpMRI-targeted confirmatory biopsy after one year from the diagnosis, according to the international guidelines

Sponsors & Collaborators

  • Università Vita-Salute San Raffaele

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-07
Primary Completion
2028-05-07
Completion
2030-03-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06866041 on ClinicalTrials.gov